Same case as 2134265-2014-03353.It was reported that during a coronary stenting procedure the sterile field was compromised.It was reported that the technician took the non sterile secondary packaging of the fg,promus premier, stent into the sterile filed.The stent was implanted without incident.
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Device is combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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